U.S. patent number 4,190,154 [Application Number 05/875,063] was granted by the patent office on 1980-02-26 for sterile package.
This patent grant is currently assigned to Bausch & Lomb Incorporated. Invention is credited to James A. Clark.
United States Patent |
4,190,154 |
Clark |
February 26, 1980 |
Sterile package
Abstract
An improved sterilizable, sterility maintaining, peelable
package for sterile products constructed of an envelope, a peeling
film inserted in and extending from one end of the envelope and a
closure around the exterior of the package which hermetically seals
the package, and seals the peeling film to the envelope. The
peeling film is constructed of a sheet of sterilizable plastic film
having a density appreciably dissimilar from the density of the
envelope.
Inventors: |
Clark; James A. (Honeoye Falls,
NY) |
Assignee: |
Bausch & Lomb Incorporated
(Rochester, NY)
|
Family
ID: |
25365143 |
Appl.
No.: |
05/875,063 |
Filed: |
February 6, 1978 |
Current U.S.
Class: |
206/438; 206/363;
206/439 |
Current CPC
Class: |
B65D
75/40 (20130101); B65D 75/5855 (20130101); B65D
75/38 (20130101) |
Current International
Class: |
B65D
75/00 (20060101); B65D 75/52 (20060101); B65D
75/58 (20060101); B65D 75/40 (20060101); B65D
75/38 (20060101); A61B 019/02 () |
Field of
Search: |
;206/438,439,363,364,365 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
988693 |
|
Apr 1965 |
|
GB |
|
1395257 |
|
May 1975 |
|
GB |
|
Primary Examiner: Ross; Herbert F.
Attorney, Agent or Firm: Parker; Frank C.
Claims
What is claimed is:
1. An improved sterilizable, sterility maintaining, peelable
package for sterile products which comprises:
envelope means;
peeling film means inserted in and extending from one end of said
envelope means for opening a portion of said package and removal of
said sterile product without contamination;
said peeling film means extending for only a portion of the length
of said envelope means in order to facilitate the opening of said
envelope means while at the same time minimizing the quantity of
material required;
said peeling film means comprising an untreated sheet of
sterilizable plastic film having a density appreciably dissimilar
from the density of said envelope means; and
closure means for hermetically sealing said envelope means and for
hermetically sealing said peeling film means to said envelope
means.
2. The invention according to claim 1 in which said envelope means
comprises a seamless tubular film member.
3. The invention according to claim 1 in which said closure means
comprises:
a linear grid of fused heat seals which hermetically seal said
envelope means thereby preventing the contamination of said sterile
product; and
a top seal portion of said closure means being curved in order to
facilitate initiation of the peeling of said seal.
4. The invention according to claim 1 in which said peeling film
means has a cut-out portion which circumscribes a portion of said
sterile product and positions said sterile product away from said
closure means thereby preventing the contamination of said sterile
product upon the peeling open of said package.
5. The invention according to claim 4 further comprising:
side positioning seal means for limiting the opening of said
package to the area proximate said cut-out portion of said peeling
film thereby allowing said sterile package to be held in an open
position while retaining said sterile product.
6. The invention according to claim 5 further comprising:
hermetically sealed inner pouch means enclosed about said sterile
product which cooperate with said side positioning seal means to
position said sterile product away from said closure means and
which provide a secondary sterile barrier in the event that the
primary package is compromised.
7. The invention according to claim 1 in which the invention
further comprises:
tack seal means proximate to a first end of said peeling film means
for attaching said peeling film to a first side of said envelope
means thereby facilitating the peeling of a second side of said
envelope means from the combination of said peeling film means and
said first side of said envelope means.
8. The invention according to claim 7 further comprising:
slit means integrally formed lengthwise along a portion of the
sides of said envelope means for freeing said second side of said
envelope from said first side so that said second side may be
peeled from the combination of said peeling film means and said
first side of said envelope means.
9. The invention according to claim 1 in which said envelope means
comprises low density polyethylene.
10. The invention according to claim 1 in which said peeling film
means comprises high density polyethylene.
11. The invention according to claim 1 in which said envelope means
comprises:
a top film member; and
a bottom film member,
said closure means hermetically sealing said top film member to
said bottom film member proximate to the top, bottom and sides of
said package, with said peeling film member juxtaposed therebetween
and extending therefrom.
12. The invention according to claim 11 in which said top film
member comprises low density polyethylene film.
13. The invention according to claim 10 in which said bottom film
member comprises low density polyethylene film.
14. The invention according to claim 2 in which said tubular film
and said peeling film consists of a material which does not deposit
residue or debris when torn thereby preventing deposit of such
particles or residue into said package when opened.
15. The invention according to claim 1 in which said envelope means
and said peeling film means consist of a material which does not
deposit residue or debris when torn, thereby preventing deposit of
such particles or residue into said package when opened.
16. The invention according to claim 1 in which said envelope means
and said peeling film means are constructed of a material which
does not leave a feathered edge when peeled, thereby preventing
contamination of said sterile product during removal from said
package.
Description
BACKGROUND OF THE INVENTION
This invention relates, generally, to flexible packaging devices,
and more specifically to sterilizable, sterility maintaining,
peelable packages for sterile products.
One of the major advances in modern health care technology has been
the mass production of presterilized medical instruments and
supplies, packaged in disposable, sterility maintaining flexible
pouches and envelopes. The use of such disposable packaging
eliminates the need for resterilization of the medical devices
contained therein by hospitals, doctors, or medical personnel when
use of the sterile product is desired. Consequently, the use of
such packages has been widespread. One of the problems associated
with such packages, however, is how to open them without having the
sterile product contact a torn edge, a portion of which would be on
the outside of the package and therefore contaminated.
Previous attempts to overcome these difficulties, such as those
shown in the patents of Spees, U.S. Pat. No. 3,053,385; Lonholdt et
al, U.S. Pat. No. 3,315,802; Armentrout, U.S. Pat. No. 3,547,257;
Rohde, U.S. Pat. No. 3,186,628; Hermanson et al, U.S. Pat. No.
3,123,210; Lasky, U.S. Pat. No. 3,926,311; Link, U.S. Pat. No.
3,724,651; Powell, U.S. Pat. No. 3,332,549 and Kurtz, U.S. Pat. No.
3,256,981, have met with varying success. However, many of the
peelable packages disclosed in the listed prior patents require
expensive laminations or coatings on one or more layers of the
package. Additionally, experience has shown that the peelability of
such packages is irregular due to variations in coating density,
film thickness, sealing temperatures and sealing pressure.
Accordingly, it is an object of the present invention to provide
sterile packages which effectively seal the sterile products
contained within against contamination;
It is an additional object of the invention to provide a sterile
package with reliabile peelability characteristics; and
It is an object of the invention to provide such packages in a form
which is easy and inexpensive to manufacture.
SUMMARY OF THE INVENTION
The present invention is an improved sterilizable, sterility
maintaining, peelable package for sterile products.
The invention comprises an envelope for packaging sterile products,
a peeling film inserted in and extending from one end of the
envelope for opening the package, and closure means for sealing the
top and bottom of the package and for sealing the peeling film to
the envelope. The peeling film is comprised of a sheet of
sterilizable plastic film, having a density appreciably dissimilar
from the density of the envelope material. In a preferred
embodiment, the envelope comprises a tube of sterilizable plastic
or paper. The peeling film is constructed of a plastic material
which may be peeled from the envelope without depositing particles
or residue on the sterile product and without leaving a feathered
edge on either the peeling film or the envelope.
The peeling film has a cut-out portion at a first end which
circumscribes the top of the sterile product. The sides of the
cut-out portion are located so that the cut-out portion positions
the sterile product away from the seals of the package when the
package is opened. Since the seals have a portion facing the
exterior of the package, that portion is contaminated. Therefore,
positioning the product away from the seals helps prevent
contamination of the product when the package is opened or the
product removed.
In a preferred embodiment, the invention includes slits integrally
formed lengthwise along opposite sides of the envelope making it
easier to peel down the front portion of the package. The scores
are positioned outside of the cut-out portion of the peeling film
so that the peeling film is interposed between the slits and the
product when the package is opened, thereby preventing
contamination.
In a preferred embodiment of the invention, the sterile package has
side positioning seals extending from the edge of the package
towards the center which position and restrain the sterile product
within the package. More importantly, the side positioning seals
limit the opening of the package to the proximity of the cut-out
portion of the peeling film, again preventing contamination of the
sterile product when opening the package.
The closure system of the package comprises a grid of fused heat
seals which hermetically seal the envelope thereby preventing
contamination of the product. The top seal portion is curved in
order to enhance the peelability of the package. The curvature
reduces the area to which shearing forces are applied, thereby
rupturing the seal before either film member. A hermetically sealed
inner pouch is enclosed about the sterile product. The pouch is the
same size as the gap between the side positioning seals in order to
help hold the pouch in place, thereby securing the product. The
pouch also provides a secondary sterile barrier in the event that
the closure system is compromised.
A tack seal at the top of the package joins the peeling film to one
side of the envelope so that the peeling film and that side of the
envelope remain tegether during peeling, thereby facilitating the
tearing down of the opposite side of the tube away from the peeling
film. In a preferred embodiment, the envelope is comprised of low
density polyethylene. The peeling film is comprised of high density
polyethylene. An example of such a material is DuPont "TYVEK" (TM)
spun bonded polyolefin.
In one embodiment the envelope is constructed of a top sheet of
sterilizable plastic material, and a bottom sheet of sterilizable
plastic material, hermetically sealed by the closure system along
the top, bottom and sides of the package.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 of the drawings is a front view of one embodiment of the
invention.
FIG. 2 of the drawings is a front perspective view of the
embodiment of the invention shown in FIG. 1 and showing the sterile
package being peeled open.
FIG. 3 of the drawings is an alternative embodiment of the
invention showing in particular envelope means constructed from top
and bottom film members.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
While this invention is susceptible of embodiment in many different
forms, there is shown in the drawings specific embodiments which
are to be considered as an exemplification of the principles of the
invention and not intended to limit the invention to the
embodiments illustrated. Improved sterilizable peelable package 30,
shown in FIG. 1, comprises envelope means 31 which is constructed
of sterilizable plastic material or sterilizable paper. A peeling
film 32 is inserted in and extends from one end 33 of envelope
means 31. Peeling film 32 is constructed of a material having a
higher density than that of envelope means 31 which improves the
peelability of the package. Closure system 34 hermetically seals
envelope means 31 proximate to the top 35 and bottom 36 of package
30 and also seals peeling film 32 to envelope 31. Peeling film 32
is sealed by closure means 34 across portions 37 and 38 of sides 39
and 40 of package 30. Due to peeling film 32, closure means 34 may
be peeled open and sterile product 41 removed without
contamination. In a preferred embodiment envelope means 31 is
constructed from a tube of sterilizable film.
In a preferred embodiment the peeling film 32 is constructed of a
plastic, such as high density polyethylene which may be peeled from
envelope means 31 without depositing particles or residue from
either film on sterile product 41. In addition, feeling film 32,
when peeled, does not leave a feathered edge (shreds of film) on
either the peeling film 32 or envelope means 31.
Peeling film 32 has a cut-out portion 42 at first end 43 of peeling
film 32 which circumscribes portion 44 of sterile product 41.
Cut-out 42 positions sterile product 41 away from sides 39 and 40,
and away from closure means 34 when package 30 is opened, thereby
preventing contamination, since portions of sides 39 and 40 as well
as the exterior portion of closure means 34 are not within package
30 and are therefore recontaminated by the atmosphere after
sterilization.
The invention further comprises slits 45 and 46 along portions of
sides 39 and 40 of envelope means 31 which allow front portion 47
of envelope 31 to be peeled from rear portion 48. Slits 45 and 46
are positioned away from cut-out portion 42 of peeling film 32 so
that peeling film 32 is interposed between the sterile product 41
and slits 45 and 46 thereby preventing contamination when the
package is opened.
Side positioning seals 49 and 50 limit the amount that package 30
can be opened to the area proximate first end 43 of peeling film
32. This prevents sterile product 41 from contacting a contaminated
portion of the package.
Closure means 34 comprise a linear grid of fused heat seals
proximate the top 35 and bottom 36 of package 30, which prevent
contamination of sterile product 42 within the package. Top seal 51
which is a portion of closure means 34 is curved in order to
enhance the peelability of closure means 34. Curving of the top
seal provides a minimum area of seal to rupture initially. Once the
seal begins to peel, resistance to further peeling is reduced.
As further shown in FIG. 1 of the drawings, the invention includes
a hermetically sealed inner pouch 52 enclosed about sterile product
41 within peelable package 30 which is sized to precisely fit
between side positioning seals 49 and 50, so that pouch 52 can
later be removed from package 30 without touching closure means 34
or slits 45 and 46. In addition, pouch 52 provides a secondary
sterile barrier in the event that the primary package 30 is
compromised, i.e. that the seals fail or the package is
punctured.
The invention further includes a tack seal 53 proximate to first
end 33 of envelope means 31 for attaching peeling film 32 to a rear
portion 48 of envelope means 31. Thus, peeling film 32 and rear
portion 48 of envelope means 31 remain together when front portion
47 of envelope means 31 is peeled from package 30. The combined
stiffness of the two films makes peeling front portion 47
easier.
FIG. 2 of the drawings shows peeling film 32 of package 30 being
held in one hand and front portion 47 of envelope means 31 being
peeled open. Top seal 51 of closure means 34 has already been
peeled open. The result is that sterile product 41 is exposed for
removal from package 30 without contacting a contaminated
surface.
In an alternative embodiment of the invention, improved sterilized
package 60, shown in FIG. 3, envelope means 31 comprises a top film
member 61 and a bottom film member 62. Peeling film 63 is
interposed between top film member 61 and bottom film member 62.
Closure means 64 hermetically seals the top portion 65, bottom
portion 66 and sides 67 and 68 of sterile package 60.
As in the previous embodiment, peeling film 63 may be peeled from
top film member 61 or bottom film member 62 without depositing
particles or residue on sterile product 69. In addition, peeling of
peeling film 63 does not leave a feathered edge either on peeling
film 63 or on top film member 61 or bottom film member 62.
Peeling film 63 has a cut-out portion 70 at first end 71 of peeling
film 63 which circumscribes portion 72 of sterile product 69.
Cut-out 70 acts as a shield to prevent sterile product 69 from
contacting closure 64. Contamination of sterile product 69 is
thereby prevented when product 69 is removed from package 60.
Additionally, side positioning seals 73 and 74 limit the amount the
package can be opened to the area proximate cut-out 70, further
insuring that sterile product 69 will not contact a contaminated
surface. Side positioning seals 73 and 74 also restrain sterile
product 69 within package 60.
As further shown in FIG. 3, closure system 64 comprises a linear
grid of heat seals which fuse top film member 61 and bottom film 62
to each other and to peeling film 63. Closure system 64
hermetically seals package 60 against contamination. Additionally,
top seal 75 of closure system 64 is curved. This curvature reduces
the area of the seal being stressed and results in a shearing of
the seal rather than one of the film members.
Package 60 also includes a hermetically sealed inner pouch 76
enclosed about sterile product 69 which is held between side
positioning seals 73 and 74 in order to further secure product 69.
Pouch 76 also provides a secondary sterile barrier in the event
that primary package 60 is compromised.
Additionally shown in FIG. 3 of the drawings is a tack seal 77 near
the top 65 of package 60 for attaching the peeling film 63 to the
bottom film 62 so that peeling film 63 remains attached to bottom
film 62 when top film 61 is peeled. This double layer of film
increases the stiffness of the surface from which top film 61 is
peeled, thereby making it easier to peel.
The foregoing description and drawings merely explain and
illustrate the invention and modifications and variations may be
made therein without departing from the scope of the invention.
* * * * *